Journal Article

Rationale and design of VICAD-RISK study: Visualization of coronary artery disease for modification of risk factors

Grove, Erik Lerkevang, Jensen, Jesper Møller, Laustsen, Sussie, Busk, Martin, Nørgaard, Bjarne Linde, Kragholm, Kristian, Pedersen, Kamilla Bech, Mortensen, Martin Bødtker, Sand, Niels-Peter Rønnow, Vedsted, Peter, Winther, Simon, Kulasingam, Archana, Hammid, Osama, Kanstrup, Helle

2025

Overview

•NOCAD is a progressive condition, emphasizing the importance of early prevention.•Statins help manage NOCAD, but adherence to therapy remains suboptimal.•VICAD-RISK study is a randomized controlled study on disease visualization in NOCAD.•The study assesses the impact of image visualization on LDL reduction after 1 year.•Results may improve patient engagement and adherence to preventive therapies. With the increasing use of coronary computed tomography angiography (CTA), the prevalence of patients with nonobstructive atherosclerotic coronary artery disease (NOCAD) is growing. Presence of NOCAD is associated with an increased risk of an unfavorable clinical outcome. Therefore, guideline-directed preventive strategies such as lipid-lowering therapy with statins are important. This study aims to assess whether visualization of personal CTA images to patients with a new diagnosis of NOCAD facilitates reduction of low-density lipoprotein (LDL) cholesterol (primary endpoint), improves statin adherence, influences the perception of statin-associated side effects, and modifies the coronary atherosclerotic phenotype. The VICAD-RISK study is a Danish multicenter randomized trial including statin naïve patients suspected of chronic coronary syndrome with a new diagnosis of NOCAD determined by first-line coronary CTA. A total of 273 patients will be randomized 1:1:1 into; (1) usual care; representing current clinical practice of general practitioner follow-up; (2) low-intensity intervention; specialized nurse consultation, or (3) high-intensity intervention; similar to group 2 and presentation of the personal CTA-images. All participants, including the intervention groups, will be followed at the discretion of their general practitioner. Research follow-up including biochemistry measurements, and coronary CTA investigation will be repeated for all participants after 12 months. The VICAD-RISK study evaluates whether personal CTA image visualization in patients with a new diagnosis of NOCAD improves reduction of LDL cholesterol. ClinicalTrials.gov, NCT06413641, www.clinicaltrials.gov.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Angina pectoris / Angiography / Arteriosclerosis / Atherosclerosis / Biomarkers / Blood pressure / Cardiology / Cardiovascular disease / Case reports / Cholesterol / Cholesterol, LDL - blood / Computed tomography / Computed Tomography Angiography - methods / Coronary Angiography - methods / Coronary artery disease / Coronary Artery Disease - blood / Coronary Artery Disease - diagnostic imaging / Coronary Artery Disease - drug therapy / Coronary vessels / Denmark - epidemiology / Diagnosis / Disease prevention / Female / Health risks / Heart diseases / Hospitals / Humans / Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use / Hypotheses / Lipids / Low density lipoprotein / Male / Medical imaging / Middle Aged / Patients / Phenotypes / Quality of life / Questionnaires / Randomized Controlled Trials as Topic / Rehabilitation / Risk Factors / Side effects / Smoking cessation / Statins / Vein & artery diseases / Visualization